Best Practices, LLC conducted this research for a client company seeking to improve and enhance its manufacturing operations in the face of increased regulatory scrutiny. The U.S. Food and Drug Administration has cited various companies for deficiencies in quality control. These deficiencies resulted in extraordinary attention being placed on the companies™ quality functions to avoid the potential for manufacturing shutdowns by the U.S. government Š severely impacting product launch, supplies, patient health, and corporate profitability. Such companies expend significant resources to regain credibility and create a much improved quality function. This particular study sought to understand the world-class practices and performance of pharmaceutical companies™ quality organizations as benchmarks to compare structure, staffing, roles and responsibilities in the quality function.

The Best Practices LLC research team identified seven top companies to participate in this study, most of which were recently noted for exceptional quality execution and overall standing in the quality arena. Others have made significant changes and improvements to their system, which we documented as well. The research team conducted oral interviews and written surveys of executives at each of these companies, seeking great detail on each aspect of the quality function. The study identified the systems, approaches, and practices to which these leading executives attribute their success. Our research identified performance gaps Œ which gave executives a path along which the client company may pursue quality excellence.

This white paper includes a sample of data analysis and practices for the quality function.